US10617516B2 - Directional tissue expander - Google Patents

Abstract

An expandable mammary implant including a shell having an anterior face and a posterior face. The anterior has an upper pole portion and a lower pole portion meeting at an apex, and an injection zone for receiving fluid therethrough to inflate the implant. A reinforcement material is coupled to the shell in a reinforcement zone. The reinforcement material is coupled to the shell so as to at least coincide with the upper pole portion and a peripheral rim portion that extends from the posterior face upwardly into said anterior face by a predetermined distance.

Description

FIELD OF THE INVENTION

The present invention relates generally to the field of expandable implants, and more particularly to expandable mammary implants.

BACKGROUND

Tissue expanders are devices that are implanted beneath the skin and then gradually inflated to stretch the overlying tissue. Such expanders are used to create a pocket for receiving a permanent prosthesis and/or to generate increased skin surface area so that skin can be utilized for grafting or reconstruction.

In the case of mammary implants, tissue expanders are used to create the mammary pocket that will ultimately receive the permanent mammary implant. These expanders are commonly formed of a silicone polymer shell. After implantation, saline or some other fluid is periodically injected into the expander over time, for example through an injection port, until the desired sized pocket is achieved.

With known mammary tissue expanders, as the inflation process continues, resistive pressure from the tissue on the anterior side of the expander can cause the expander to expand in undesired directions (i.e., axially and laterally). In order to minimize the undesired expansion, most surgeons select a smaller expander than needed and overinflate the expander to 200-300% of the rated volume of the expander. This allows the surgeon to utilize the smaller starting foot print of a smaller expander to accommodate for the undesired axial and lateral expansion. Overinflating a smaller expander is undesirable for various reasons. Although expanders are technically tested up to twice their nominal inflation volume, 200-300% inflation could reduce the safety margin of the device. Further, since the footprint is small, at 200-300% inflation the inflated shape is not anatomically correct, but rather is more round or ball-like, which could lead to rotation or flipping over of the implant within the tissue pocket.

Thus, is would be desirable to provide an expandable mammary implant that better provides for the appropriate directional tissue expansion for any given size.

SUMMARY OF THE INVENTION

The present invention provides an expandable mammary tissue implant including a shell having an anterior face and a posterior face, with the anterior face having an upper pole portion and a lower pole portion meeting at an apex, and an injection zone for receiving fluid therethrough to inflate the implant. The implant further includes a reinforcing material coupled to the shell in a first reinforcement zone and a second reinforcement zone. The first reinforcement zone forms at least a peripheral rim portion that extends from a periphery of the posterior face upwardly into the anterior face by a predetermined distance, and a first end of the first reinforcement zone is located in the upper pole region of the anterior face. The second reinforcement zone extends from a first end that substantially abuts or overlaps the first end of the first reinforcement zone, and along at least a portion of the anterior face of the shell such that the entire upper pole of the shell is reinforced as between the first and second reinforcement zones.

In one embodiment, the first reinforcement zone further extends along the entire posterior face of the shell. The predetermined distance that the first reinforcement zone extends upwardly into the anterior face of the shell may vary around the periphery of the posterior face of the shell. In yet another embodiment, the second reinforcement zone extends along at least a portion of the anterior face of the shell to an apex of the shell.

The reinforcing material may be a mesh material, and may further be a polyester mesh. The shell may be made of silicone.

In yet another embodiment, the reinforcing material has varying elasticity properties at different locations, and may have an elasticity gradient in a predetermined direction.

According to yet another embodiment, the implant further includes at least one insert member positioned entirely within and extending across an interior of the shell, and coupled to an interior surface of the shell. The insert member may be sized and shaped so as to be coupled to the interior of the shell around an entire perimeter of the insert member, and may further be coupled to the interior of the shell in a location substantially adjacent to an upper periphery of the first reinforcement zone. Alternatively, the insert member may be sized and shaped so as to be coupled to the interior of the shell around a portion of a perimeter of the insert member, and have a cutout therein. The insert member may further include a plurality of apertures therethrough, and/or have an elasticity gradient in a predetermined direction.

According to yet another embodiment, the at least one insert member may be coupled to the interior surface of the shell at first and second ends thereof.

Also provided is an expandable mammary implant including a shell having an anterior face and a posterior face, with the anterior having an upper pole portion and a lower pole portion meeting at an apex, and an injection zone for receiving fluid therethrough to inflate the implant. The implant further includes a reinforcement material coupled to the shell in a reinforcement zone. The reinforcement material is coupled to the shell so as to at least coincide with the upper pole portion and a peripheral rim portion that extends from the posterior face upwardly into the anterior face by a predetermined distance.

In another embodiment, the reinforcement zone may further extend from the upper pole portion along the anterior face by a predetermined distance, with the predetermined distance being less than or equal to the distance to the apex of the shell. The reinforcement zone may further coincide with the entire posterior face of the shell. In yet another embodiment, the predetermined distance that the first reinforcement zone extends upwardly into the anterior face of the shell varies around the periphery of the posterior face of the shell.

According to yet further alternate embodiments, the reinforcing material may be a mesh material, such as a polypropylene mesh, and the shell may be made of silicone.

In a further embodiment, the reinforcing material has varying elasticity properties at different locations, and may have an elasticity gradient in a predetermined direction.

An insert member may further be included that is positioned entirely within and extends across an interior of the shell, and is coupled to an interior surface of the shell. It may be sized and shaped so as to be coupled to the interior of the shell around an entire perimeter of the insert member, and may further be coupled to the interior of the shell in a location substantially adjacent to an upper periphery of the first reinforcement zone.

The insert member may further include a plurality of apertures therethrough, and/or have an elasticity gradient in a predetermined direction.

Alternatively, the insert member may be a strip coupled to the interior surface of the shell at first and second ends thereof.

The present invention also provides an expandable mammary tissue implant including a shell having an anterior face and a posterior face, with the anterior face having an upper pole portion and a lower pole portion meeting at an apex, and an injection zone for receiving fluid therethrough to inflate the implant. The implant further includes a reinforcing material coupled to the shell in a reinforcement zone, wherein the reinforcement zone covers the upper pole and a peripheral zone extending from the peripheral rim of the posterior face into the anterior face such that upon inflation, expansion of the implant occurs disproportionately in the lower pole region.

These and other objects, features and advantages of the present invention will be apparent from the following detailed description of illustrative embodiments thereof, which is to be read in connection with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross-sectional side view an exemplary prior art mammary tissue implant;

FIG. 2 is a side view of an exemplary mammary tissue implant according to the present invention;

FIG. 3 is a perspective view of the device ofFIG. 2;

FIG. 4ais an exemplary illustration of a possible transition zone between reinforced and non-reinforced portions of a shell;

FIG. 4billustrates the mammary implant ofFIG. 3 further including a reinforcing material having varying elastic properties;

FIGS. 5a-5cillustrate exemplary embodiments of a reinforcing material having varying elastic properties along its length;

FIG. 6ais a cross-sectional, perspective view illustrating a mammary tissue implant according to the present invention including an insert member;

FIG. 6billustrates an alternate configuration for a mammary implant having an insert member;

FIGS. 6cand 6dillustrate the mammary implant ofFIG. 3 and further including an insert member; and

FIGS. 6e-6hillustrate various alternate embodiments of insert members.

DETAILED DESCRIPTION

FIG. 1 shows a cross-sectional side view of an exemplary prior artmammary tissue expander4. The expander has aposterior face10 that lies substantially flat and is placed against a patient's chest wall, and ananterior face5 that faces outward from the chest wall when implanted. Theanterior face5 includes an upper pole region15 (i.e., the upper portion of the shell when the implant recipient is standing), a lower pole region20 (i.e., the lower portion of the shell when the implant recipient is standing), and an apex25 (corresponding to the point at which the nipple would be in a natural breast) separating the upper pole region and the lower pole region. Theouter shell35 of theexpander5 is typically made of a silicone material and includes an injection port or other valve or self-sealingzone40 through which saline or another fluid is injected over time into the containedinner region30. In this manner, the volume of the expander can be increased over time until the desired size pocket is achieved.

With known expanders such as that shown inFIG. 1, although the overall shape of the expander when fully inflated as shown is somewhat anatomically correct, it has been found that when in use within the body, expansion does not occur in an anatomically correct or desired manner. This is because the expander ofFIG. 1 is shown in air, and known expanders are designed and tested in air. Due to the minimal resistance of the surrounding air, an expander with an outer shell comprised of a substantially uniform material will expand to the final shape of that shell. In the body, however, the surrounding tissue and muscles counteract expansion, and a device with a substantially uniform outer shell will expand according to the path of least resistance, often determined by the varying resistance of the surrounding tissue. For mammary prostheses, this typically results in deformity of the outer shell to a more pancake like shape, with the anterior projection of the lower pole expansion being less than planned or desired, and lateral and axial expansion more than desired. As indicated previously, in an effort to increase the anterior projection of lower pole expansion, surgeons often pick undersized expanders having a smaller footprint (as against the chest wall), and over inflate them.

The present invention overcomes the problems described above and provides for expansion in the appropriate direction in an appropriate sized implant. More specifically, the implants described herein allow for minimized lateral and vertical expansion, while providing a more anatomically correct profile with less fullness in the upper pole region and more fullness and anterior expansion in the lower pole region. As shown in the illustrative embodiment inFIG. 2, the implant of the present invention includes reinforcement at various locations along the shell to provide for minimal expansion at various desired locations and full expansion at other predetermined locations, to result in an expander that has desired and varied expansion characteristics around its surface area when in actual use within the body.

Theexpander100 ofFIGS. 2 and 3 similarly includes aposterior face110 and ananterior face105 that includes anupper pole region115, alower pole region120, and an apex125. As indicated previously, the posterior face is substantially flat when the shell is inflated and is the portion of the shell that lies against the patient's chest wall. The posterior face is defined byperiphery141. The expander also includes aninjection zone40. The injection zone may be an injection dome of the well-known type as illustrated inFIG. 1, may be a self-sealing area, or any other suitable device/area through which fluid can be injected and/or removed from the implant.

Theouter shell135 of theexpander100 further includes one or more reinforcement zones, wherein a reinforcing material limits the expandability of the outer shell material. According to one embodiment, the outer shell is made of silicone, and the reinforcing material is a mesh, such as a polyester mesh, although any suitable implantable mesh may be used. Alternatively, the reinforcing material may be a silicone sheet having an elasticity equal to or lower than the elasticity of the shell. The area of the shell having a reinforcing material coupled to it will have an overall elasticity less than any unreinforced area regardless of the elasticity of the reinforcing material. In a preferred embodiment, however, the reinforcing material has elasticity that is substantially lower than the elasticity of the shell.

Further, any other suitable material may be used that adequately functions to restrict expansion of the shell by having an elasticity that is equal to or less than that of the shell material. Exemplary other materials include silicone based polymers, composite materials, polyurethane, polypropylene, and other biocompatible polymeric materials. The reinforcing material may be coupled to the shell by covering the mesh with an un-vulcanized silicone sheet and pressing it into the shell such that the un-vulcanized silicone sheet essentially acts as a glue. The strength of the formed connection can be improved by curing the silicone at an elevated temperature over a period of time (i.e., 315-350 degrees Fahrenheit for approximately 30 minutes).

The embodiment ofFIG. 2 includes afirst reinforcement zone140 and asecond reinforcement zone150, both of which are illustrated with cross-hatching. Thefirst reinforcement zone140 has afirst end146 and asecond end144, and includes at least aperipheral rim portion148 that extends from theperiphery141 of theposterior face110 upward into theanterior face105 by a predetermined distance to anupper periphery103. The predetermined distance may be constant around the periphery, or may vary along the periphery as shown inFIG. 2. The first reinforcement zone may further extend so as to coincide with the entirety of the posterior face, or some portion thereof. Thefirst reinforcement zone140 restricts lateral and axial expansion of the shell in the peripheral area immediately adjacent to the posterior face. In this manner, the surgeon need not choose an expander having a smaller posterior face than desired in order to account for undesired lateral expansion around the perimeter of the base of the implant.

The embodiment ofFIG. 2 further includes asecond reinforcement zone150. Afirst end152 of the second reinforcement zone preferably substantially abuts or overlaps afirst end148 of thefirst reinforcement zone140 so that theupper pole region115 of the expander is entirely reinforced as between the first and second reinforcement zones. In this manner, upon being infused with fluid, the expander is unable to appreciably expand in the upper pole region. The second reinforcement zone extends from thefirst end152 and along at least a portion of theanterior face region105 of the expander, essentially forming a reinforced “hinge” like structure centered around theupper pole region115, and having hinge points149 on both sides where the first and second reinforcement zones first meet and start to overlap or abut each other. In certain embodiments, the reinforcement material covers from about 25% to about 80% of the shell surface area, and more preferably from about 50% to about 75% of the shell surface area.

In this manner, expansion of the upper pole region beyond the intended shape is restricted, while more freely allowing desirable expansion of thelower pole region120. In one embodiment, the second reinforcement zone extends substantially to the apex125 of the shell.

Although the embodiment above is described as having first and second pieces of reinforcing material, one skilled in the art will readily understand that the reinforcement zones can be established with a single piece as well.

In a further aspect of the present invention, the reinforcing material may be designed so that the degree of elasticity of the material varies at different locations. With a uniform reinforcing material, particularly when the elasticity of the reinforcing material is much different than that of the shell, it may be the case that somewhat sharp transition zones appear between the reinforced regions of the shell and the unreinforced regions. An exemplary illustration is shown inFIG. 4a, wherein theimplant shell400 is reinforced along theposterior face402 and aperipheral region404 similar to that described above. The difference in elasticity between the shell material and the reinforced zone may cause a sharp transition at thepoint405 where the reinforced shell meets the unreinforced shell as demonstrated inFIG. 4awith an implant shell shown in three stages of inflation. To minimize this possible effect, the reinforcing material may have varying elasticity properties at different locations, or simply have an elasticity gradient (gradually decreasing or increasing elasticity properties) in a given direction. In a preferred embodiment, elasticity of the reinforcing material increases in the direction towards the areas which are free of reinforcing material, or have less reinforcing material, so that the reinforcing material immediately adjacent the non-reinforced areas has the highest elasticity. This can be accomplished by various means including, for example, providing apertures in the reinforcing material that vary in size and/or density along the length of the material. Exemplary embodiments are shown inFIGS. 5a-5c, withFIG. 5aillustrating circular apertures of varyingdiameter500aalong the length of the material, andFIGS. 5band 5cillustrating varying slit-like aperture arrangements500b,500calong the length of the material. Further, the thickness of the mesh or other material may vary along the length to achieve this result. In another embodiment, both varying aperture size and/or aperture density (i.e., the number of apertures in a given area) along the length of the material and/or simultaneously varying thickness along the length of the material are contemplated to provide the desired elasticity gradient.

FIG. 4billustrates theimplant shell400 having reinforcingzone420 with a lower elasticity proximal to theposterior face402 and a higher elasticity in theperipheral region404, with elasticity increasing due to higher density ofapertures422 cut in thematerial420. As can be seen fromFIG. 4b, elasticity is higher closest to thetransition point405 where the reinforced shell meets the unreinforced shell.

In yet another embodiment of the invention, the device illustrated inFIGS. 2 and 3 may further include an additional, separate reinforcinginsert member600 as illustrated inFIGS. 6aand 6b. The insert member is positioned entirely within theinterior space601 of theshell635. In the illustrated embodiment, the insert member is sized and shaped to span the entire interior or the shell and is secured to theinterior surface607 of the shell around itsentire periphery602, preferably at a location substantially adjacent to theupper periphery603 of thefirst reinforcement zone644. The insert member helps minimize undesired effects at a transition zone of the type described above, and further assists in maintaining the desired shape of the implant during expansion. The insert member may further include holes, apertures or the like606, as illustrated inFIG. 6b, in order to allow movement of fluid within the shell as it is expanded. In alternate embodiments, the insert member may be in the form more of a “tether” or the like, such as a strip (or multiple strips) extending across the interior of the shell at any desired location, rather than having a configuration that substantially spans the entire interior. The insert member may be formed of any suitable material having an elasticity that is suitable to increase the shell's resistance to outward expansion, such as Dacron™, polypropylene, Dacron™-silicone composite, etc. The insert member may be secured to the inside of the shell using un-vulcanized silicone sheeting and heat, silicone-based adhesives, solvent-based bonding, diffusion bonding, ultrasonic welding, laser-spot welding, and other techniques known to a skilled artisan.

FIGS. 6cand 6dillustrate the implant ofFIG. 3 havingalternate insert member600 therein. In this embodiment, the insert member (shown in dotted lines inFIG. 6c) is positioned in a substantially similar manner as illustrated inFIGS. 6aand 6b, but has an alternate “half-moon” type shape, as shown clearly inFIG. 6d.

The reinforcinginsert member600 may have various other shapes and configurations, examples of which are shown inFIGS. 6e-6h. InFIG. 6f, theinsert member600 has acutout610 generally shaped/positioned so that its first andsecond points650,651 correspond to or substantially align with thehinges149 where the first and second reinforcement zones begin to overlap (seeFIG. 2). InFIG. 6e, theinsert member600 has alarge size aperture618 which is generally shaped/positioned so as to correspond to the location of the hinges. The size and location oflarge size aperture618 are selected to locally increase elasticity ofinsert member600, with area of thelarge size aperture618 being from about 20% to about 40% of area ofinsert member600, most preferably from about 20% to about 30% of area ofinsert member600.FIG. 6gillustrates aninsert member600 with at least oneoptional aperture606 and an array ofslits614 providing for increased elasticity of theinsert member600. Thearray614 is generally shaped/positioned so as to correspond to the location of the hinges.

Finally,FIG. 6hillustrates aninsert member600 having a plurality ofapertures615 providing for increased elasticity ofinsert member600, withapertures615 generally shaped/positioned so as to correspond to location of hinge point as described previously.

Although illustrative embodiments of the present invention have been described herein with reference to the accompanying drawings, it is to be understood that the invention is not limited to those precise embodiments and that various other changes and modifications may be effected herein by one skilled in the art without departing from the scope or spirit of the invention.

Claims (6)

What is claimed is:

1. An expandable mammary tissue implant comprising:

a shell having an anterior face and a posterior face having a periphery, the anterior face having an upper pole region and a lower pole region meeting at an apex, and an injection zone for receiving fluid therethrough to inflate the implant;

a first reinforcing material having (i) a peripheral rim portion that extends from the periphery of said posterior face and (ii) an upper periphery, said first reinforcing material coupled to the shell such that the first reinforcing material does not extend along the entire anterior face;

a second reinforcing material coupled to the shell and extending along a portion of the anterior face of the shell;

wherein the first reinforcing material overlaps or abuts the second reinforcing material, at or adjacent the upper periphery of the first reinforcing material and in at least two locations on opposite sides in the upper pole region thereby forming a hinge point on each of said opposite side of the upper pole region, and

wherein a portion of the lower pole region is not reinforced by either the first or second reinforcing material;

further comprising at least one insert member within the implant, that lies in a plane substantially parallel to the posterior face of the shell and is coupled to the implant in one or more locations substantially adjacent to the upper periphery of the first reinforcing material the at least one insert member has at least one cutout or aperture positioned to correspond to or substantially align with the hinge point on each of said opposite side of the upper pole region.

2. The implant according toclaim 1, wherein the first reinforcing material further extends within the implant along the entire posterior face of the shell.

3. The implant according toclaim 1, further comprising

an injection zone in the upper pole region of the anterior face for receiving fluid therethrough to inflate the implant; and

a vertical tether member having first and second ends and a central region therebetween having an aperture therethrough, wherein the central region is coupled to the anterior face of the implant at a location such that the injection zone is positioned within the aperture in the central region, and wherein the first and second ends of the vertical tether member are coupled to the posterior face of the implant.

4. The implant according toclaim 1, wherein the at least one insert member is a strip coupled at first and second ends thereof in said one or more locations substantially adjacent to the upper periphery of the first reinforcing material.

5. The implant according toclaim 1, further comprising

an injection zone in the upper pole region of the anterior face for receiving fluid therethrough to inflate the implant; and

a vertical tether member having first and second ends and a central region therebetween having an aperture therethrough, wherein the central region is coupled to the anterior face of the implant at a location such that the injection zone is positioned within the aperture in the central region, and wherein the first and second ends of the vertical tether member are coupled to the posterior face of the implant.

6. The implant according toclaim 5, wherein the at least one insert member has at least first and second apertures therein, and the vertical tether member has first and second vertical portions on either side between the central region and the respective first and second ends, and

wherein the first and second vertical portions extend through said respective first and second apertures of the insert member.

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